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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K170511
Device Name NeoFuse HA Enhanced PLIF/TLIF
Applicant
Ht Medical, LLC
6316 E 102nd St.
Tulsa,  OK  74137
Applicant Contact Robert Compton
Correspondent
Acknowledge Regulatory Strategies, LLC
2834 Hawthorn St.
San Diego,  CA  92104
Correspondent Contact Allison Komiyama
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/21/2017
Decision Date 04/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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